Pfizer, BioNTech Plan to File EUA Request for COVID-19 Vaccine Within Days

Pfizer and BioNTech today announced that their coronavirus disease 2019 (COVID-19) vaccine candidate showed 95% efficacy and no serious adverse effects (AEs), according to a final analysis of its phase 3 trial.

Additionally, the vaccine showed an observed efficacy over 94% in adults older than 65 years of age. 

Based on these data, the companies expect to submit its request for emergency use authorization to the FDA within days, Pfizer said in a press release.

The mRNA-based vaccine BNT162b2 met all of the study’s primary efficacy end points, with analysis of the data indicating a vaccine efficacy rate of 95% (P<.0001) in participants without prior SARS-CoV-2 infection, as well as in those with and without prior infection, at 7 days after the second dose.

Pfizer previously reported results from an interim analysis of the study at the beginning of November that showed a vaccine efficacy rate above 90% for BNT162b2.

The phase 3 trial began on July 27 and has enrolled 43,661 participants to date, 41,135 of whom have received a second dose of the vaccine candidate as of November 13, 2020. According to Pfizer, the first primary objective analysis is based on 170 cases of COVID-19, as specified in the study protocol, of which 162 cases of COVID-19 were observed in the placebo group versus 8 cases in the BNT162b2 group.

No serious safety concerns related to the vaccine have been reported by the Data Monitoring Committee. Based on a review of a randomized subset of at least 8000 adult participants, the vaccine was shown to be well tolerated, with most solicited AEs resolving shortly after vaccination.

Based on current projections, Pfizer and BioNTech expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021.

The news comes after Moderna reported just a few days ago that its messenger RNA vaccine candidate for COVID-19 , mRNA-1273, showed a 94.5% efficacy rate in its first interim analysis.

Reference

Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints. News release. Pfizer; November 18, 2020. Accessed November 18, 2020. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine